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Comparative Trial of Nitrazepam and Corticotropin

Fritz Dreifuss, MD; Jacqueline Farwell, MD; Gregory Holmes, MD; Clifford Joseph, MD; Lawrence Lockman, MD; Jack A. Madsen, MD; Chester J. Minarcik, Jr, MD; A. David Rothner, MD; D. Alan Shewmon, MD

Arch Neurol. 1986;43(11):1107-1110.

Abstract
• Fifty-two patients were enrolled in a four-week randomized multicenter study comparing nitrazepam and corticotropin in the treatment of infantile spasms. The drugs' efficacy was evaluated in 48 patients, all less than 2 years of age. Both treatments resulted in a statistically significant reduction in spasm frequency from that at baseline, but the difference between treatments was not significant. The number of patients who experienced side effects was similar in the two treatment groups, but the adverse effects encountered among the patients treated with corticotropin were qualitatively more severe and required the discontinuation of treatment in six patients.

Author Affiliations
From the University of Virginia Medical Center, Charlottesville (Dr Dreifuss); Children's Orthopedic Hospital, Seattle (Dr Farwell); Newington (Conn) Children's Hospital (Dr Holmes); Hoffmann-La Roche Inc, Nutley, NJ (Dr Joseph); University of Minnesota School of Medicine, Minneapolis (Dr Lockman); University of Utah Medical Center, Salt Lake City (Dr Madsen); Children's Hospital, Denver (Dr Minarcik); The Cleveland Clinic (Dr Rothner); and UCLA Center for the Health Sciences (Dr Shewmon). Dr Holmes is now with the Medical College of Georgia, Augusta; Dr Joseph is now also with University of Medicine and Dentistry of New Jersey, New Jersey Medical School, Newark; and Dr Minarcik is now with Cooper Hospital University Medical Center, Camden, NJ.

Footnotes
Accepted for publication July 25, 1986.

Reprint requests to Hoffmann-La Roche Inc, Bldg 115/5, Nutley, NJ 07110 (Dr Joseph).

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